Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M15/00—Inhalators
  • A61M15/0065—Inhalators with dosage or measuring devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M15/00—Inhalators
  • A61M15/0086—Inhalation chambers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M15/00—Inhalators
  • A61M15/0001—Details of inhalators; Constructional features thereof
  • A61M15/0013—Details of inhalators; Constructional features thereof with inhalation check valves
  • A61M15/0016—Details of inhalators; Constructional features thereof with inhalation check valves located downstream of the dispenser, i.e. traversed by the product
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
  • A61M16/20—Valves specially adapted to medical respiratory devices
  • A61M16/208—Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M15/00—Inhalators
  • A61M15/009—Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/10—Tube connectors; Tube couplings
  • A61M2039/1077—Adapters, e.g. couplings adapting a connector to one or several other connectors
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/22—Valves or arrangement of valves
  • A61M39/24—Check- or non-return valves

Definitions

• the present invention relates to a spacer and/or components therefor.
• the invention relates to a flow valve for use in a spacer.
• Sufferers of asthma or chronic obstructive pulmonary disease often use a metered dose inhaler in order to inhale a bronchodilatory drug such as Salbutimol into their lungs, thereby opening up their pathologically constricted airways.
• a metered dose inhaler in order to inhale a bronchodilatory drug such as Salbutimol into their lungs, thereby opening up their pathologically constricted airways.
• a bronchodilatory drug such as Salbutimol into their lungs
• Patent No. 5,816,240 describes a spacer having: a chamber with a mouthpiece; an inspiratory valve with a radially extending disc and an axially extending plug retainer, the inspiratory valve being configured for opening on inspiration by a patient and closing upon expiration by a patient; and an expiratory valve comprising a radially extending ring, the inspiratory valve being configured for opening upon expiration by a patient and closing upon inspiration by a patient.
• a disadvantage of prior art spacers such as the one mentioned above may be the use of two valves which both move during inspiration and expiration, potentially causing increased resistance to flow and leading to overly complex designs.
• Another disadvantage with these types of spacers may be the need for ultrasonic welding of the chamber components, potentially adding to the complexity and reducing efficiency of assembly during manufacture.
• the invention provides a spacer for delivering a medicinal substance to a user, the spacer comprising:
• a chamber comprising,
• a vent for expulsion of air from the second reservoir and a valve located at least partly within the chamber, the valve being adapted to,
• the valve may be a unitary flow valve.
• the valve may comprise a retaining portion which remains engaged with or retained by a part of the chamber. Further, the valve may comprise a first flow control portion which is anchored by the retaining portion.
• the first flow control portion may be adapted to open during user inspiration, thereby enabling forward flow of the medicinal substance, and adapted to close during user expiration, thereby substantially limiting backflow of the medicinal substance.
• the first flow control portion may comprise at least one substance flap member.
• the substance flap member may have a free edge which is adapted to flap open during opening of the second flow control portion and adapted to flap closed during closing of the first flow control portion.
• the first flow control portion may comprise multiple flap members.
• the first flow control portion may comprise two substance flap members having free edges which are adapted to close together when the first flow control portion is closed and adapted open apart when the first flow control portion is open.
• the substance flap members may resemble a duck bill.
• the first flow control portion may comprise four substance flap members having free edges which are adapted to close together when the first flow control portion is closed and adapted open apart when the first flow control portion -is open.
• the free edges may form a cross slit.
• the substance flap members may form quadrant portions.
• the first flow control portion may form a domical-like shape.
• the first flow control portion may be angled upwardly and inwardly by between 1 and 20 degrees. In a suitable form it may be angled upwardly and inwardly by between 5 and 15°. Preferably it may be angled upwardly and inwardly by about 10°.
• the first flow control portion may be between 5 and 15mm in height. Preferably it may be about 10mm in height.
• the valve may comprise a second flow control portion which is anchored by the retaining portion.
• the second flow control portion may be adapted to close during user inspiration, thereby substantially limiting outside air from flowing through the vent into the second reservoir,
• the second flow control portion may be adapted to open during expiration, thereby enabling expulsion of air through the vent from the second reservoir.
• the second flow control portion may comprise an air flap member.
• the air flap member may have a free edge which is adapted to flap open during user expiration and adapted to flap closed during user inspiration.
• the air flap member may have a circumferential free edge. It may be disc shaped.
• the first control portion may be centrally placed in the valve.
• the second flow control portion may surround the first control portion.
• the retaining portion may be located between the first control portion and the second control portion.
• the chamber may comprise a first chamber portion.
• the first chamber portion may, along with the valve, substantially define the first reservoir.
• the first chamber portion may comprise a tubular member
• the chamber may comprise a second chamber portion.
• the second chamber portion may, along with the valve, substantially define the second reservoir.
• the second chamber portion may comprise a vented member.
• the vented member may define the vent.
• the second chamber portion may comprise, a mouthpiece which is attached to or continuous with the vented member.
• the retaining portion of the valve may be fixedly sandwiched between the tubular member and the vented member.
• the vented member may comprise a central chamber aperture. Further, the vented member may comprise a series of radially disposed apertures which surround the chamber aperture. The radially disposed apertures may form part or all of the vent.
• the inlet may comprise a flexible portion with an aperture which can adapt to and snugly receive medicinal substance delivery devices of various shapes and sizes.
• the inlet may form part of a base of the chamber which is detachable from the remainder thereof.
• User inspiration and/or user expiration may be passive, or mechanically assisted or controlled.
• a user's breathing may be assisted or forced by a machine such as a ventilator. .
• the outlet may comprise the mouthpiece.
• the outlet may be adapted for insertion into the user's mouth.
• the outlet may be adapted for connection with a device which may be disposed in or about the user's mouth.
• the outlet may be connected with an oxygen mask placed over the user's mouth and nose, or a ventilator tube extending into the user's mouth.
• the medicinal substance may comprise a drug.
• the medicinal substance may comprise a powder in suspension, an atomised liquid, or a fluid.
• the invention may provide a unitary valve for use with a spacer chamber for delivering a medicinal substance to a user, the spacer chamber comprising, first and second reservoirs, an inlet for admission of the medicinal substance into the first reservoir, an outlet for withdrawal of the medicinal substance from the second reservoir, and a vent for expulsion of air from the second reservoir, the valve comprising:
• first flow control portion which is adapted to be anchored by the retaining portion, the first flow control portion being adapted to open during user inspiration, thereby allowing forward-flow of the medicinal substance from the first reservoir to the second reservoir, and adapted to close during user expiration, thereby substantially limiting backflow of the medicinal substance from the second reservoir to the first reservoir, and
• a second flow control portion which is adapted to be anchored by the retaining portion, the second flow control portion being adapted to close during user inspiration, thereby substantially limiting inflow of air through the vent into the second reservoir, and adapted to open during expiration, thereby allowing expulsion of air from the second reservoir through the vent.
• Fig. 1 is an above axonometric view of a spacer in accordance with a preferred embodiment of the invention.
• Fig. 2 is a beneath axonometric view of the spacer
• Fig. 3 is an exploded axonometric view of the spacer from above;
• Fig. 4 is an exploded axonometric view of the spacer from below;
• Fig. 5 is a top view of a valve of the spacer in its resting configuration
• Fig. 6 is an above axonometric view of the valve in its resting configuration
• Fig. 7 is a side view of the valve in its resting configuration
• Fig. 8 is a beneath axonometric view of the valve in its resting configuration
• Fig. 9 is a bottom view of the valve in its resting configuration
• Fig. 10 is a top view of the valve in its inspiration configuration
• Fig. 1 1 is an above axonometric view of the valve in its inspiration configuration
• Fig. 12 is a side view of the valve in its inspiration configuration
• Fig. 13 is a bottom axonometric view of the valve in its inspiration configuration
• Fig. 14 is a bottom view of the valve in its inspiration configuration
• Fig. 15 is a top view of the valve in its expiration configuration
• Fig. 16 is an above axonometric view of the valve in its expiration configuration
• Fig. 17 is a side view of the valve in its expiration configuration
• Fig. 18 is a bottom axonometric view of the valve in its expiration configuration
• Fig. 19 is a bottom view of the valve in its expiration configuration
• Fig. 20 is a diagrammatic view showing a spacer positioned for use, wherein an outlet of the spacer is placed in the mouth of a user and a medication inhaler is inserted into an inlet of the spacer;
• Fig. 21 is a diagrammatic view showing flow of medication from the inhaler into the spacer, and the flow pathway during user inspiration; and, Fig. 22 is a diagrammatic view of the spacer in use showing the flow pathway during user expiration.
• a spacer which is suitable for delivering aerosolised medication 4 to a user 6 (see Fig. 21 in particular).
• the spacer 2 comprises a Makrolon polycarbonate chamber 8 and a flow valve 18 located within the chamber 8.
• the chamber 8 comprises:
• the flow valve 18 is adapted to:
• the chamber 8 comprises first and second chamber portions, the first chamber portion comprises a tubular member 22, and a detachable base member 24.
• the second chamber portion comprises a vented member 26 connected atop the tubular member 22, and a mouthpiece 28 connected atop vented member 26.
• the base member 24 comprises a cylindrical ridge 30 which is stepped inwardly and upwardly from a curved cylindrical ring 32.
• a circular flange 34 projects inwardly from the cylindrical ring 32, the circular flange 34 having a series of spaced circular apertures 36.
• the tubular member 22 comprises a cylindrical wall 38. Towards the bottom of the cylindrical wall 38 is a slight inwardly projecting ridge 40. The inwardly projecting ridge 40 articulates with the cylindrical ridge 30 during fitted insertion of the base member 24 into the tubular member 22.
• An attachment portion 42 is stepped in atop the cylindrical wall 38, the attachment portion 42 comprising a series of attachment ridges 44.
• a curved top portion 46 extends inwardly and upwardly from attachment portion 42, the curved top portion 46 ending to define a chamber aperture 48.
• Vented member 26 comprises an attachment portion 48 having inwardly disposed attachment grooves 50 which are adapted for permanent engagement with the attachment ridges 44, thereby enabling permanent attachment of the vented member 26 with the tubular member 22 when assembling the product during manufacture.
• a series of spaced rectangular pillars 52 extend upwardly from the attachment portion 48, the pillars 52 defining the lower and side boundaries of a series of spaced circumferential apertures 54.
• the top boundary of the circumferential apertures is defined by a circular band 56 which is fixedly grasped by and within the top ends of the rectangular pillars 52. The top edge of the circular band 56 is angled in for attachment to mouthpiece 28.
• the mouthpiece 16 comprises an attachment rim 64 for attachment with the circular band 56 of the vented member 26.
• a cupola portion 66 curves upwardly and inwardly from the attachment rim 64, before continuing into the tubular mouth portion 68, into which mouth aperture 70 opens.
• the spacer 2 further comprises a flexible circular Santoprene rubber inlet moulding 72.
• the inlet moulding 72 comprises an externally facing C- shaped ring 74, with its upper and lower flanges grasping the circular flange 34 of the base member 24 therebetween.
• the "C” is a series of spaced mould pillars 76 which interconnect the upper and lower flanges of the mouth.
• the mould pillars 76 extend through respective apertures 36 of the base member 24, thereby firmly holding the inlet moulding 72 in place with respect to the base member. 24.
• Extending inwardly from the base of the C-shaped ring 74 is a flexible inhaler flange 78.
• the inhaler flange 78 defines an inhaler aperture 84 which in this instance corresponds with the size and shape of an inhaler mouthpiece 80 (see Figure 20) of a commonly available Salbutimol inhaler 82. It should be noted, however, that the flexible nature of inlet moulding 72, and in particular the inhaler flange 78, enables the inhaler aperture 84 to fitably adapt to other inhalers and medication administering devices of various shapes and sizes.
• Silicone flow valve 18 comprises a domical-like first flow control portion 86.
• the first flow control portion 86 extends upwardly from a second flow control portion in the form of a circular flow ring 88 which is substantially flat when in its resting state inside the chamber 8.
• a functional retaining portion 90 At and about the intersection between first flow control portion 86 and flow ring 88, is a functional retaining portion 90. The retaining portion is retained between the top free edge of the top portion 46 (which defines the chamber aperture 94 of the tubular member 22), and the under-surface of the retaining ring 60 (of the vented member 26).
• the retaining portion 90 of flow valve 18 remains fixed, sandwiched between the tubular member 22 and the vented member 26.
• the retaining portion 90 includes a thickening in the flow valve 18 at the intersection between the first flow control portion 86 and the flow ring 88.
• the thickening itself comprises a small circular internal ridge 92 which may assist in limiting slipping of the flow valve 18 between the edge of the chamber aperture 94 and the retaining ring 60.
• the outer free edge of the flow ring 88 also comprises a thickened free edge 96.
• the domical-like first flow control portion 86 comprises a cross slit 98 which is closed when the valve is in its resting state.
• the cross slit 98 marks the free edges of four quadrant portions 100;
• the remainder of each of the quadrant portions is defined by a U-shaped edge 102, the arms of which extend downwardly from the ends of the cross slit 98.
• a crown shaped portion ' 104 extends upwardly from retaining portion 90, with the triangular peaks of the crown extending between, and meeting with, the U-shaped edges 102 of the quadrant portions 100.
• the flow ring 88, U-shaped crown portion 104, and quadrant portions 100 of the flow valve 18 are of 3mm thickness.
• the diameter of the flow ring 88 is 43.5mm, while the diameter of the first flow control portion is 24.3mm at its base and 22mm at its top.
• the first flow control portion 86 is angled in from its base to its top.
• the U-shaped crown portion 104 is angled upwardly and inwardly by about 10°, although it is envisaged that the angle may be between 1 and 20 degrees in alternative embodiments.
• the height of the first flow control portion 86 when closed is 10mm.
• valve 18 is shown in its inspiration configuration when retained within the chamber 8.
• the free edges of quadrant portions 100 flap upwardly and outwardly, thereby creating a four point star shaped inhalation opening 106 through which air flows, (as indicated by arrow 108) during user inspiration.
• FIGS 15-19 show the expiration configuration of flow valve 18 when inside the chamber 8.
• the cross slit 98 is again closed, but the flow ring 88, which is anchored at retaining portion 90, flaps downwardly at its free edge 96 as a result of pressure from expiratory flow (as indicated by arrows 1 10).
• the spacer 2 may be used in the following manner:
• Salbutimol inhaler 82 is inserted snugly into the inhaler aperture 84 of the flexible inlet moulding 72, and then the mouth portion 68 of mouthpiece 28 is inserted into the mouth of the user 6.
• the flow valve 18 can be seen in its resting configuration with both the first flow control portion 86 and the flow ring 88 being closed.
• the Salbutimol inhaler's pressurised canister 1 10 is depressed by the user 6, (as indicated by arrow 1 12), thereby causing aerosolised fluid Salbutimol particles to be sprayed out through inhaler mouth piece 80 (as indicated by arrow 114) so that the Salbutimol particles (as indicated by arrow 21 ) collect within the first reservoir 10 of the chamber 8.
• the user 6 then inspires causing reduced air pressure in the second reservoir 12 of the chamber 8.
• This causes the first flow control portion 86 of flow valve 18 to flap open and air in the second reservoir 12, (which includes Salbutimol fluid particles 21 ) to be drawn through the inhalation opening 106, into the second reservoir 12, and through to the mouth of the user 6 (as indicated by arrow 1 16).
• the user 6 then exhales, (with expiratory flow being indicated by arrows 1 18 and expiratory air flows back towards flow valve 18, forcing the quadrant portions 100 of the first flow control portion 86 to flap back to their closed position, and forcing the flow ring 86 to flap open, thereby opening access to vent 20 which enables expiratory air to flow out of chamber 8.

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• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Pulmonology (AREA)
• Life Sciences & Earth Sciences (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Heart & Thoracic Surgery (AREA)
• Hematology (AREA)
• Anesthesiology (AREA)
• Animal Behavior & Ethology (AREA)
• Veterinary Medicine (AREA)
• Biomedical Technology (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Emergency Medicine (AREA)
• Biophysics (AREA)
• Medicinal Preparation (AREA)
• Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
• Check Valves (AREA)
• Respiratory Apparatuses And Protective Means (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)

Priority Applications (1)

Applications Claiming Priority (2)

Publications (3)

Family

ID=46050220

Family Applications (1)

Country Status (12)

Cited By (1)

Families Citing this family (34)

Family Cites Families (17)

• 2010
  • 2010-11-10 AU AU201014848F patent/AU333977S/en not_active Expired - Lifetime
• 2011
  • 2011-02-24 PT PT118395979T patent/PT2678060T/pt unknown
  • 2011-02-24 WO PCT/AU2011/000200 patent/WO2012061866A1/en not_active Ceased
  • 2011-02-24 PL PL11839597.9T patent/PL2678060T3/pl unknown
  • 2011-02-24 CA CA2816598A patent/CA2816598C/en active Active
  • 2011-02-24 JP JP2013538002A patent/JP5647736B2/ja active Active
  • 2011-02-24 US US13/884,429 patent/US8905020B2/en active Active
  • 2011-02-24 ES ES11839597.9T patent/ES2572643T3/es active Active
  • 2011-02-24 EP EP11839597.9A patent/EP2678060B1/de active Active
  • 2011-02-24 AU AU2011326322A patent/AU2011326322B2/en active Active
  • 2011-04-15 CA CA140182F patent/CA140182S/en not_active Expired - Lifetime
  • 2011-05-06 TW TW100302215F patent/TWD146253S/zh unknown
  • 2011-05-10 US US29/391,514 patent/USD682989S1/en active Active
• 2013
  • 2013-04-25 ZA ZA2013/03028A patent/ZA201303028B/en unknown
• 2016
  • 2016-07-12 CY CY20161100658T patent/CY1117781T1/el unknown

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